5afb4a9d-7c70-4aea-94e9-fc410444be13UpdatePublished92026-01-152017-10-302025-08-08Not in Commercial Distribution00846468084530PrimaryGS1Fortilink-TS IBF System65-TS-TRL22-1765-TS-TRL22-17793384496Pioneer Surgical Technology, Inc.1Fortilink-TS IBF System Trial Spacer, 17mm (H), 22mm (L)falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(906)226-9909regulatory@exalta.com46479Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.falseActiveMAXIntervertebral Fusion Device With Bone Graft, LumbarDevice Size Text, specify17mm (H), 22mm (L)falsetrueMoist Heat or Steam Sterilization